Patent Docs

CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 2

November 18, 2019

By Kevin E. Noonan —

October 14th was a busy day at the Patent Trial and Appeal Board (PTAB) for the current interference over CRISPR technology (No. 106,115). The Junior Party (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC") filed its Substantive Motion No. 1 for priority benefit to its application No. 61/652,086, and its Opposition to the Senior Party's (the Broad Institute, Harvard University and MIT) Substantive Motion No. 1. The Broad for its part filed three additional substantive motions (Contingent Motion No. 2 to substitute the count; No. 3 to designate claims as not corresponding to the count; and No. 4, for priority benefit to the Broad's application No. 61/736,528). This post will discuss The Broad's Substantive Motion No. 2; future posts will review the remaining Broad motions and CVC's Substantive Motion No. 1.

This motion seeks to substitute the Count; Count 1 of the interference as declared is:

An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

or

A eukaryotic cell comprising a target DNA molecule and an engineered and/or non-naturally occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-— CRISPR associated (Cas) (CRISPR-Cas) system comprising
    a) a Cas9 protein, or a nucleic acid comprising a nucleotide sequence encoding said Cas9 protein; and
    b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA-targeting RNA; wherein the single molecule DNA-targeting RNA comprises:
        i) a targeter-RNA that is capable of hybridizing with a target sequence in the target DNA molecule, and
        ii) an activator-RNA that is capable of hybridizing with the targeter-RNA to form a double-stranded RNA duplex of a protein- binding segment,
    wherein the activator-RNA and the targeter-RNA are covalently linked to one another with intervening nucleotides; and
    wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule, whereby said system is capable of cleaving or editing the target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule.

The Broad's proposed Count 2 is:

A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule, the method comprising:
    contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly lnterspaced Short Palindromic Repeats (CRISPR)-CRISPR associated Cas) (CRISPR-Cas) system comprising:
        a) a Cas9 protein, and
        b) RNA comprising
            i) a targeter-RNA that is capable of hybridizing with the target sequence of the DNA molecule or a first RNA comprising (A) a first sequence capable of hybridizing with the target sequence of the DNA molecule and (B) a second sequence; and
            ii) an activator-RNA that is capable of hybridizing to the targeter-RNA to form an RNA duplex in the eukaryotic cell or a second RNA comprising a tracr sequence that is capable of hybridizing to the second sequence to form an RNA duplex in the eukaryotic cell,
    wherein, in the eukaryotic cell, the targeter-RNA or the first sequence directs the Cas9 protein to the target sequence and the DNA molecule is cleaved or edited or at least one product of the DNA molecule is altered.

The distinction the Broad makes is between embodiments of CRISPR methods that are limited to "single-molecule guide RNA" (aka "fused" or "covalently linked" species), versus embodiments that encompass single-molecule and "dual molecule" species (wherein the in the latter versions the "targeter-RNA" and "activator-RNA" as recited in the proposed Count are not covalently linked). The Broad argues that this Count should be adopted by the Board because it "properly describes the full scope of the interfering subject matter between the parties because both parties have involved claims that are generic, non-limited RNA claims." The brief also argues that proposed Count 2 "sets the correct scope of admissible proofs [i.e., their own] for the breakthrough invention described by the generic claims at issue in these proceedings—the successful adaption of CRISPR-Cas9 systems for use in eukaryotic environments," which The Broad contends current Court 1 (in either alternative) does not.

The brief also requests that the Broad be accorded benefit to its provisional application U.S. Serial No. 61/736,527, and that CVC not be accorded benefit to any of its earlier applications (which just maintains the status quo requiring CVC to move to be accorded benefit), because CVC's applications-in-interference were not accorded benefit when this interference was declared.

The Broad's argument in support of its motion is that Count 1 is too narrow for encompassing just a subset of the parties' involved claims. In particular, the brief asserts that most of the Broad's involved clams encompass "non-limited" RNA systems and methods. Similarly, the brief argues that CVC itself has many claims directed to non-limited RNA systems and methods and has entire applications that do not recite claims to non-limited RNA systems and methods. The Broad asserts that Count 1 does not permit the Broad to rely on its earliest and best proofs of invention, which the brief states is "plainly unfair." This unfairness would preclude the Broad from establishing what the brief terms "the fundamental breakthrough – the invention of use of CRISPR in eukaryotic cells" (emphasis in brief). Failing to substitute the Count would instead improperly focus the priority question on who invented the single molecule modification. Colorfully, the brief declares that "[a]llowing the interference to proceed with Count 1 would permit the (single molecule RNA) tail to wag the (breakthrough use of CRISPR in eukaryotic cells) dog."

The claims include such generic species that encompass both single-molecule and dual molecule embodiments, according to the brief, but the breakthrough invention was adapting CRISPR-Cas9 to be used in eukaryotic cells, an argument the Broad has used consistently here and in the earlier '048 interference to distinguish its claims from CVC's. The brief notes that the first disclosure of this use was in a scientific journal article by some of the Broad's named inventors that "has become by far the most frequently cited CRISPR publication" as evidence of the groundbreaking nature of the invention. Also cited (as a reminder to the Board of its earlier decision, the basis thereof and the Federal Circuit's affirmance of it) is the Board's earlier decision that there was no reasonable expectation of adapting CRISPR for use in eukaryotic cells as further evidence of the breakthrough nature of (as asserted herein) the Broad's invention.

It is then the Broad's turn to allege that its opponent is attempting to avoid this interference, "on fair terms," the question of which party invented use CRISPR in eukaryotic cells. The Broad sets out its allegations against CVC, first for "tr[ying] to engineer" the '48 interference on "environment-free" proofs, and now for "trying to engineer a single-molecule RNA eukaryotic CRISPR interference" that would prevent the Broad from relying on its best (i.e., early dual molecule RNA) proofs. Whereas, according to the Broad, CVC is attempting to rely on reduction to practice of single-molecule RNA systems that "occur[ed] over a year after Broad's alleged earliest reductions to practice" (emphasis in brief). The consequence of using Count 1 would raise "'the anomalous possibility' that CVC could win priority as to the full scope of the commonly claimed invention (and Broad could lose all of its designated claims, including non-limited RNA claims) merely by CVC proving priority based on a later reduction to practice on a limited count, even though Broad made the broad invention of the designated claims first."

Further, echoing arguments made in its Substantive Motion No. 1, using such an "artificially narrow count" would permit CVC to avoid the estoppel effects of the decision in the '048 interference, according to the Broad. The brief cites a CVC press release touting the risk this interference provokes that "jeopardizes all of the Broad's CRISPR patents as (somehow) being evidence that CVC is unfairly trying to obtain an undeserved windfall in its interference strategy (ignoring the fact that it was the PTO that declared the interference and determined the Count).

The Broad then provides the Board with, in the alternative, either proceeding with this interference under Count 1 but finding that non-limited RNA claims do not correspond to the Count, or proceeding with a two Count interference, with one Count directed to using CRISPR in eukaryotic cells and the other directed to single-molecule RNA species.

The brief then sets forth the differences between non-limited and single-molecule RNA versions of CRISPR, and its history of the development of its eukaryotic cell embodiments of CRISPR technology, making distinction between single-molecule RNA and dual molecule RNA embodiments, and liberally illustrating the brief with diagrams from its own NIH grant applications and scientific references. The brief then synopsizes the decision in the earlier '048 interference based on there being no reasonable expectation of success in achieving eukaryotic cell applications of CRISPR based on earlier applications of CRISPR in prokaryotic cells. This was followed by the Broad's description of the CVC's further prosecution of the applications in this interference.

Section V of the brief adopts the format of motions in interference practice of setting forth the basis for the PTAB to grant the motion. For motions such as this one, the standard is that the current Count does not encompass the full scope of the interfering subject matter and excludes the Broad's best proofs. See, Grose v. Plank, 15 U.S.P.Q.2d 1338, *4-6 (B.P.A.I. 1990); Kondo v. Martel, 220 U.S.P.Q. 49, *2-3 (B.P.A.I. 1983); Nelson v. Drabek, 212 U.S.P.Q. 98 *2-3 (Comm'r 1979). The interfering subject matter, according to the Broad, is claims to non-limited RNA (i.e., single molecule and double molecule species of RNA) for use in eukaryotic cells; the grounds for this allegation is that each party has involved claims to this subject matter. The crux of this argument (echoed throughout) is that "the Count should be set to resolve the parties' dispute as to who made the breakthrough necessary to make CRISPR Cas9 systems and methods work in a eukaryotic environment first, not just which party first disclosed 'fused' or 'covalently-linked' guide RNA," citing In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Doing otherwise (i.e., maintaining Count 1) would result (according to the Broad) in the Board awarding priority "not to the party that invented [use of CRISPR in eukaryotic cells] first, but rather to whomever can show they made the single molecule modification to that invention first."

The Broad contends that Count 1 puts all their claims at risk (a complaint contrary to arguments that the Board should settle the interference (in their favor) once an for all. And the brief reiterates the allegation that this is fundamentally unfair because CVC made a "its deliberate decision to not include eukaryotic CRISPR claims in the 048 Interference, in which Broad could have used proofs commensurate in scope with the scope of its claims."

Next the Broad sets forth its arguments why the PTAB should grant the motion and substitute this Count 2. First, according to the brief, Count 2 is consistent with the scope of the parties' claims and properly describe the scope of the interfering subject matter. Because the Broad has proofs relating to using dual molecule RNA in CRISPR prior to CVC's claims-in-interference, and limiting their proofs to single molecule embodiments (which cannot antedate CVC's claims in interference) would limit the extent to which the Broad could counter CVC's priority proofs. And as they have argued elsewhere, CVC's own public statements are used to imply that Berkeley and its colleagues are pursuing the broader scope because it puts essentially all the Broad's patents at risk (ignoring for the purpose of its argument that CVC did not provoke this interference or suggestion this Count No. 1, both of which are sua sponte creatures of the PTAB itself).

With regard to its "best proofs" argument, the Broad cites caselaw (Univ. of S. California v. DePuy Spine, Inc., 473 F. App'x 893, 23 895 (Fed. Cir. 2012)) the Board's regulations (37 C.F.R. § 41.121, § 41.201, and § 41.208(a)(2)); and the MPEP (MPEP § 2304.02(b)) in support of its position. The brief supplements these citations with what CVC is "likely" to argue, i.e., "that Broad is barred from relying on some of its best proofs supporting priority as to its non-limited claims, which are the vast majority of its involved claims." Those "best proofs" are duel-molecule guide RNA embodiments used in eukaryotic cells that the Broad contends are entitled to a filing date in 2012 earlier than any possible CVC priority date, based inter alia on affidavit testimony submitted with its brief in addition to declarations and laboratory evidence submitted during ex parte prosecution. And of course the Broad reminds the Board that the consequence could be awarding priority to a later inventor, contrary to the purpose of interferences.

In the alternative, the Broad argues that should the PTAB determine that the estoppel the Broad argued in Substantive Morton No. 1 does not apply, and that the interference will proceed under Count 1, the PTAB should designate the Broad's claims directed to dual-molecule RNA embodiments as not corresponding to Count 1, or sua sponte declare a two Count interference.

The brief next turns to the benefit of priority to which they are entitled under Count 2, specifically the Zhang B1 reference and any intervening patents or applications claiming priority to USSN 61/736,527 (Zhang B1), illustrated by this diagram and supported by evidence set forth in Appendix 3:

The brief then sets forth, in detail, element-by-element, support in Zhang B1 for the recited elements of the Count. Also recited is the asserted basis for priority in each of the related, later-filed applications set forth in the diagram, as well as the '945, '965, '445, '356, '814, '839, '616 and '713 Patents and '551 application, thus reaffirming that these patents-in-interference were entitled to the priority claim.

In contrast, the Broad argues that CVC is not entitled to any priority, based in part because there was no benefit of priority was accorded by the Board when this interference was declared.

Section V.F. then argues that Count No. 2 recites subject matter that is patentable over the prior art, when considered in light of the Broad being entitled to the December 12, 2012 filing date of the Zhang B1 reference, first by analogy to the subject matter of the Count in the '048 Interference (and, extensively, the PTAB's decision in that interference and the Federal Circuit' affirmance thereof) and also because the Broad's claims corresponding to Count No. 2 had been allowed over the prior art of record.

Finally, the Broad's brief argues which of its claims correspond to Count No. 2:

USP 8,697,359 – Claims 1-20 (all); USP 8,771,945 – Claims 1-29 (all); USP 8,795,965 – Claims 1-30 (all); USP 8,889,356 – Claims 1-30 (all); USP 8,906,616 – Claims 1-30 (all); USP 8,945,839 – Claims 1-28 (all); USP 8,993,233 – Claims 1-6 and 8-43; USP 8,999,641 – Claims 1-28 (all); USP 9,840,713 – Claims 1-41 (all); and UPS 14/704,551 – Claims 2, 4-8, and 12-18

And which do not (and arguments in support of its designations). The brief also sets out which of CVC's claims so correspond (all of them).
USPTO Subject Matter Eligibility October Update: Example 46

November 17, 2019

By Michael Borella —

Last month the U.S. Patent and Trademark Office published an update ("October Update") to its subject matter eligibility guidance. As we noted at that time, the October Update is more evolutionary than revolutionary, and primarily serves to provide clarifications to the more substantive January Guidance. Nonetheless, the USPTO did provide four additional examples applying its revised test for subject matter eligibility under 35 U.S.C. § 101 to hypothetical claims. Here, we discuss Example 46.

The background, of course, is 2014's Alice Corp. vs. CLS Bank Int'l Supreme Court holding. Therein, the Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101. These parts are denoted by the USPTO as steps 2A and 2B, respectively (step 1 is to determine whether the claimed invention is one of the four statutory categories of subject matter set forth in § 101, and is rarely at issue in practice).

Under step 2A, one must decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then under step 2B one further decides whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion. Elements or combinations thereof that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle. While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

The January Guidance breaks the first part of the Alice test into two sub-steps (let's call them 2A(i) and 2A(ii) for purposes of clarity). In the former, one determines whether the claim recites a judicial exception, such as an abstract idea. In the latter, one determines further "whether the recited judicial exception is integrated into a practical application of that exception."

To focus the analysis, the January Guidance indicates that, under step 2A(i), all abstract ideas should fall into one of three categories: mathematical concepts, certain methods of organizing human activity, and mental processes. Think of these as the "Three M's" — math, money, and mental steps.

If the analysis moves on to sub-step 2A(ii), then one determines "whether the claim as a whole integrates the recited judicial exception into a practical application of the exception." Such a claim "will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception."

Example 46 applies this test to four claims directed to an invention for obtaining and analyzing identification and behavioral data of livestock animals, such as dairy cattle. In some of these claims, cattle with aberrant behavior are identified, while in others cattle so identified are separated from the herd by a gating system or treated with a modified diet intended to address the disease of which the aberrant behavior is a symptom.

Claim 1

Claim 1 recites:

A system for monitoring health and activity in dairy livestock animals comprising:
    a memory;
    a display; and
    a processor coupled to the memory programmed with executable instructions, the instructions including
        a livestock interface for obtaining animal-specific information, wherein the animal-specific information comprises animal identification data and at least one of body position data, body temperature data, feeding behavior data, and movement pattern data; and
        a monitoring component for
            (a) comparing the obtained animal-specific information with animal information from a herd database to verify an animal's identity, and
            (b) analyzing the obtained animal-specific information to identify whether the animal is exhibiting an aberrant behavioral pattern as compared to past behavior of the animal, and
            (c) displaying the analysis results for the animal on the display.

The USPTO begins its substantive analysis by applying step 2A(i). Under the October Update, a claim recites a judicial exception when such an exception is explicitly set forth or implicitly described in the claim. Based on this interpretation, the USPTO finds that limitations (a) and (b) are an observation and an evaluation, respectively. Thus, they are "acts that can be practically performed in the human mind," and fall within the mental processes category of abstract ideas. Further, "[t]he recitation of a processor in this claim does not negate the mental nature of these limitations because the claim here merely uses the processor as a tool to perform the otherwise mental processes."

Moving on to step 2A(ii), the USPTO identifies the additional elements as "the memory, the display, the processor, the livestock interface, and limitation (c)." The first three of these elements are rapidly dismissed as being non-substantive for purposes of the § 101 analysis, because "they represent no more than mere instructions to apply the judicial exception on a computer [and] nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer." Additionally, the USPTO finds that the livestock interface is just "insignificant extra-solution activity" because it is used for data gathering and is recited at a high level of generality. Limitation (c), on the other hand, only "performs the necessary software tasks so that the result of the abstract mental process is displayed." Thus, the additional elements, when considered in isolation, do not integrate the abstract idea into a practical application.

The step 2A(ii) analysis also requires considering the additional elements in combination with one another and the rest of the claim. The USPTO states that the claim as a whole does no more than "automate the mental processes that the farmer used to perform (e.g., the mental inspection and evaluation of the livestock animals' behavior), using the computer components as a tool." Notably, "[w]hile this type of automation improves the daily life of farmers (by minimizing or eliminating the need for mentally evaluating the behavior of livestock animals), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology." Therefore, the claim fails to integrate the abstract idea.

Step 2B proceeds similarly as that of step 2A(ii). The memory, display, and processor are "at best the equivalent of merely adding the words "apply it" to the judicial exception." The livestock interface and limitation (c) are still extra-solution activity. The USPTO then states, in a rather conclusory fashion, "[e]ven when considered in combination, these additional elements represent mere instructions to apply an exception and insignificant extra-solution activity, which cannot provide an inventive concept."

As a consequence, claim 1 is ineligible.

Claim 2

Claim 2 depends from claim 1, and recites:

The system of claim 1, wherein the system further comprises
    a feed dispenser that is connected to a feed and supplement supply and is operable to dispense individualized amounts of feed and optional supplements, and
    wherein the monitoring component is further configured for
        (d) automatically sending a control signal to the feed dispenser to dispense a therapeutically effective amount of supplemental salt and minerals mixed with feed when the analysis results for the animal indicate that the animal is exhibiting an aberrant behavioral pattern indicative of grass tetany.

Since claim 2 incorporates all elements of claim 1 and two of those incorporated elements have already been found to recite an abstract idea, claim 2 also recites an abstract idea under step 2A(i).

Regarding step 2A(ii), the USPTO writes that "limitation (d) does not merely link the judicial exceptions to a technical field, but instead adds a meaningful limitation in that it can employ the information provided by the judicial exception . . . to operate the feed dispenser." Moreover, "[l]imitation (d) in combination with the feed dispenser enables the control of appropriate farm equipment based on the automatic detection of grass tetany, which goes beyond merely automating the abstract idea."

The main difference between ineligible claim 1 and eligible claim 2 is the addition of feed dispenser and how it is triggered to the latter. This adds a non-computer physical element to the claim which changes state in response to the "mental" calculations performed by the computer. This appears to be enough to transform the claimed invention into one that meets the requirements of § 101.

Another way of differentiating between claims 1 and 2 is to make an analogy to Supreme Court and Federal Circuit case law regarding the law of nature and natural phenomena exceptions. Particular, since Mayo v. Prometheus and its progeny, diagnostic method claims are almost certainly going to be found ineligible, whereas method of treatment claims can be eligible. Claim 1 reads like a diagnostic method claim (e.g., gathering patient data and determining whether there is presence or likelihood of a disease), while claim 2 reads like a method of treatment claim (e.g., administering a medicine or nutritional supplement to a patient who has been diagnosed with a disease). In that light, the USPTO is at least being consistent with the precedent, even if the correctness of that precedent has been called into question.

Claim 3

Claim 3 focuses on separating cattle identified as possibly suffering from an illness from those that do not. It recites (edited to fix apparent typographical errors in the enumeration of steps):

A method for monitoring health and activity in dairy livestock animals comprising:
    (a) causing a herd of livestock animals to enter a sorting gate that is automatically operable, wherein each animal in the herd is equipped with an animal sensor having a radio frequency transponder,
    (b) for a particular animal in the herd, obtaining, by a radio frequency reader mounted on or near the sorting gate, animal-specific information from the animal sensor when the animal sensor is within proximity to the radio frequency reader, the animal-specific information comprising animal identification data and at least one of body position data, body temperature data, feeding behavior data, and movement pattern data,
    (c) analyzing, by a processor, the obtained animal-specific information from step (b) with respect to animal information stored in a herd database to identify the animal and to determine whether the animal is exhibiting an aberrant behavioral pattern as compared to the past behavior of the animal,
    (d) automatically operating the sorting gate, by the processor sending a control signal to the sorting gate to route the animal into a holding pen when the analysis results from step (c) for the animal indicate that the animal is exhibiting an aberrant behavioral pattern, and by the processor sending a control signal to the sorting gate to permit the animal to freely pass through the sorting gate when the analysis results for the animal indicate that the animal is not exhibiting an aberrant behavioral pattern, and
    (e) repeating steps (b) through (d) for each animal in the herd.

Analyzing the claim, the USPTO observes that step (a) "does not impose any limits on how the livestock animals are caused to enter the sorting gate" while steps (b) and (c) "[do] not impose any limits on how the radio frequency reader obtains the animal-specific information, or on how the analysis of the information is accomplished." Similarly, step (d) "does not impose any limits on how the sorting gate is operated." The USPTO also notes that the conditional dependencies between the steps results in three embodiments being covered under broadest reasonable interpretation:

[A] first embodiment in which only the first condition and first action occur (all animals exhibit aberrant behavioral patterns and are thus routed to the holding pen); a second embodiment in which only the second condition and second action occur (all animals exhibit normal behavioral patterns and are thus permitted to freely pass through the sorting gate); and a third embodiment in which both conditions and both actions occur (some animals exhibit aberrant behavioral patterns and are thus routed to the holding pen, and other animals exhibit normal behavioral patterns and are thus permitted to freely pass through the sorting gate).

Applying step 2A(i), the USPTO finds that step (c) of the claim recites the abstract idea of performing an evaluation. This evaluation of "whether the animal is exhibiting an aberrant behavioral pattern as compared to the past behavior of the animal" could practically be performed in the human mind by observing the animal.

Turning to step 2A(ii), the USPTO quickly dismisses steps (a) and (e) of the claim as "nothing more than an attempt to generally link the use of the judicial exception to the particular field of livestock management," while step (b) "represents mere data gathering." The USPTO also takes issue that "steps (b) and (c) are also recited at a high level of generality and represent no more than mere instructions to apply the judicial exception using generic computer components."

On the other hand, the USPTO's view of step (d) of the claim is that, under all three embodiments, it "does not merely link the judicial exception to a technical field, but instead adds a meaningful limitation in that it employs the information provided by the judicial exception . . . to operate the gate control mechanism and route the animals." As a result, "step (d) goes beyond merely automating the abstract ideas and instead actually uses the information obtained via the judicial exception to take corrective action by operating the gate and routing the animals in a particular way." This is an integration of "the judicial exception into the overall livestock management scheme and accordingly practically applies the exception, such that the claim is not directed to the judicial exception."

Therefore, claim 3 is eligible.

Claim 4

Claim 4 uses similar language as that of claim 1, but takes the invention in a different direction. It recites:

A system for monitoring health and activity in a herd of dairy livestock animals comprising:
    a memory;
    a processor coupled to the memory programmed with executable instructions, the instructions including a livestock interface for obtaining animal-specific information for a plurality of animals in the herd, wherein the animal-specific information comprises animal identification data and at least one of body position data, body temperature data, feeding behavior data, and movement pattern data; and
    a herd monitor including (a) a radio frequency reader for collecting the animal-specific information from a plurality of animal sensors attached to the animals in the herd when the animal sensors are within proximity to the radio frequency reader, each animal sensor having a radio frequency transponder, and (b) a transmitter for transmitting the collected animal-specific information to the livestock interface.

Notably, the difference between claims 1 and 4 is that the former comprises the aforementioned comparing, analyzing and displaying steps that were found to be abstract, while the latter includes the herd monitor with its radio frequency reader and transmitter.

Under step 2A(i), the USPTO rapidly concludes that there is no judicial exception recited in the claim. Particularly, "[t]he claim does not recite any abstract ideas, such as a mathematical concept, mental process, or a method of organizing human activity such as a fundamental economic concept or managing interactions between people." Further, "[t]he system's operation, like all computers, is based on mathematical theory, but that underlying operation does not trigger an eligibility analysis because it is not set forth or described in the claim." Therefore, the claim is eligible.

Analysis

We have found the USPTO eligibility examples helpful from time to time. But some, like this one, raise new questions as it provides a few answers. First, as noted above in the discussions of claims 1 and 2, is the USPTO taking the position that improvements using generic physical components that save people time are less likely to be eligible than improvements to specific devices that have the same outcome? If so, that requires an evaluation of whether a claimed invention improves a person's performance or a machine's performance, which is difficult in practice with many software-based inventions. For example, a new algorithm that recommends a course of action for a human to take might result in both human and computer performance being enhanced.

Second, the differences in the eligibility outcome of claims 1 and 4 require some rather thin bacon slicing, and involve nuances that many examiners, PTAB judges, and attorneys might not appreciate as relevant. Further, what if we added the comparing, analyzing and displaying steps from claim 1 into claim 4? Under the October Update, claim 4 would now recite an abstract idea, but would the herd monitor result in an integration into a practical application? In a broader sense, can adding limitations to an eligible claim render it ineligible? As the slogan for an infamous tabloid publication goes, inquiring minds want to know.
Conference & CLE Calendar

November 17, 2019

November 21, 2019 – "Alphabet Soup: A Review and Summary of Post-Grant Practice at the USPTO" (Fitch Even) – 12:00 to 1:00 pm (EST)

December 2, 2019 – "Cross-Border Trends, Tactics and Strategic Insights: What European and U.S. Lawyers Should Each Know About Litigating Abroad" (Practising Law Institute) – London
Webinar on Post-Grant Practice

November 16, 2019

Fitch Even will be offering a webinar entitled "Alphabet Soup: A Review and Summary of Post-Grant Practice at the USPTO" on November 21, 2019 from 12:00 to 1:00 pm (EST). David A. Gosse of Fitch Even will provide a summary of post-grant procedures and an introduction to when, why, and how each procedure is useful (or not) to patent owners and third parties, and will also discuss the following:

• Review of post-grant procedures at the USPTO including inter partes review (IPR), post-grant review (PGR), covered business method review (CBM), supplemental examination, ex parte reexamination, and reissue applications
• Strategic purposes of the various post-grant procedures
• Tactics for petitioners and patent owners in USPTO trial proceedings

While there is no cost to participate in the program, advance registration is required. Those interested in attending the webinar can register here.
PLI Program on Litigating Abroad

November 16, 2019

Practising Law Institute (PLI) will be offering a program entitled "Cross-Border Trends, Tactics and Strategic Insights: What European and U.S. Lawyers Should Each Know About Litigating Abroad" on December 2, 2019 in London. The half-day program, which will be webcast, will cover specialized issues that impact litigators in Europe and the U.S., and explore timely international litigation issues. The program will allow attendees to:

• Master cross-border tactics and litigation strategies
• Compare European group claims and U.S. class action cases
• Describe Brexit's impact on cross-border disputes between the U.S. and UK

The registration fee for the program or webcast is $895. Those interested in registering, can do so here.
Correlation Found Between Left-Handedness and Genetic Markers Associated with Neurological Disease

November 13, 2019

By Kevin E. Noonan —

Left-handedness is a uniquely human trait, with 90% human populations globally being right-handed since the Paleolithic (extending from 3.3 million years ago to the end of the Pleistocene). A feature of motor control, the prevailing theory is that handedness is a consequence of language being "lateralized to the left hemisphere"; "lefties" are known to have more bilateral or language activation in the right hemisphere. It is also known that left-handedness is associated with several neurological disorders, including schizophrenia. But up to now no good neuroanatomical localization of the trait were known. Also unknown was the genetic basis (if any) for left-handedness (although it is known to "run in families").

The first steps to rectifying this knowledge dearth were published in Brain in September, in a paper entitled "Handedness, language areas and neuropsychatric diseases" insights from brain imaging and genetics." The paper described the use of imaging, genotype, and handedness data from UK Biobank, "a prospective cohort study of ∼500 000 participants who have allowed linkage of their physical data, including genetics, with their medical records, lifestyle questionnaires, and cognitive measures." In this study, the researchers assessed gene expression in 356,567 right-handed participants, 38,332 left-handed participants, and 6,299 ambidextrous participants. They then developed 547,011 genotyped SNPs and ~11 million imputed SNPs and utilized a set of 3144 "image-derived phenotypes" (IDP) of human brain from participants, selected to "summarize[] the information across all brain structural and functional modalities," consisting of:

[R]egional volumetric, area and thickness measures; subcortical measures of MRI modalities sensitive to e.g. venous vasculature or microbleeds and white matter lesions, white matter tract measures of physical connection ('structural connectivity') between brain regions using diffusion indices, and measures of spontaneous temporal synchronization ('functional connectivity') between pairs of brain regions.

The authors then performed genome-wide association studies (GWAS) using 547,011 mapped SNPs and ~11 million "imputed" SNPs, with the interrelationships between handedness, genetics, and brain regions illustrated by this diagram:

The results of these studies were set forth as follows. Association between handedness and brain regions showed "(i) a stronger connectivity between right and left (homologous) language networks . . . ; and (ii) a weaker connectivity between the right homologous language network and the default-mode network (DMN) and salience network ([]'stronger connectivity' corresponds to higher absolute values of partial correlation between the time courses of the two resting-state networks involved)."

Genetic studies showed three GWAS significant loci comparing handedness differences, identified as rs199512 (located at 17q21.31); rs45608532 (located at 22q11.22); and rs13017199 (located at 2q34); there was also a locus (rs3094128 located at 6p21.33) discovered by comparing the broader group of "non-right-handers" with individuals who are exclusively right-handers. These loci are correlated with expression quantitative trait loci (eQTL) for MAP2 (microtubule-associated protein 2, at rs13017199 on chromosome 2), TUBB/MICB (tubulin beta class 1, at rs3094128 on chromosome 6; and WNT3/MAPT (microtubule associated protein tau, at rs199512 on chromosome 17).

Assessing the association of these loci with neuronal development and neurodegenerative phenotypes, SNP-based enrichment analysis showed the top 2 enrichments were for Parkinson's disease and neurodegenerative disease, with the remaining 8 for other neurological disorder phenotypes. Supporting these correlations was positional gene mapping of left- and right-handers identified a set of genes highly expressed in brain tissue. Linkage disequilibrium studies showed statistically significant correlations with schizophrenia, Parkinson's disease, a tendency towards anorexia nervosa, and bipolar disorder. Specifically, the rs199512 locus (associated with MAPT) "yielded many highly significant associations with measures of white matter structural connectivity," "most strongly in tracts linking Broca's and temporoparietal junction areas (arcuate/superior longitudinal fasciculus III), i.e. specifically the same brain regions found differentially functionally-connected in our direct handedness and imaging analysis."

The strongest correlation between handedness and genotype reported from these studies were found at rs199512, relating handedness with Parkinson's disease and other "mental health phenotypes." IDP images correlated language-related tracts in brain with schizophrenia and auditory hallucinations. A correlation was found with lack of lateralization of white matter consistent with other studies showing lack of correlation with gray matter asymmetries and handedness. And these "language-related white matter tracts specifically make up the functional (homologous) language networks that differ between left- and right-handers." They further note that:

[T]hree of the four loci correlating with handedness in our GWAS are indeed associated with genes strongly involved in brain development and patterning (MAP2, TUBB/MICB, WNT3/MAPT). In particular, microtubules (MAP2, TUBB, MAPT)—as integral components of the neuronal cytoskeleton—play a key role in neuronal morphogenesis and migration. WNT3 has also been shown to act as an axon guidance molecule and, strikingly, as a gradient for retinotopic mapping along the medial-lateral axis . . . . Of note, rs3094128 is an eQTL of MICB, which is crucial to brain development and plasticity and may mediate both genetic and environmental involvements in schizophrenia.

And these authors "found a statistically significant positive correlation between left-handedness and schizophrenia using LD score regression."

The paper concludes by saying that "[t]his study thus represents an important advance in our understanding of human handedness and offers mechanistic insights into the observed correlations between chirality and microtubules in the brain, and suggests an overlap of genetic architecture between handedness and certain neurodegenerative and psychiatric phenotypes."
USPTO News Briefs

November 12, 2019

By Donald Zuhn —

USPTO to Offer Seminars on DOCX

In a Patent Alert e-mail distributed today, the U.S. Patent and Trademark Office announced that it will be offering several seminars on how to use DOCX for EFS-Web filings and on PAIR. The DOCX Information Sessions will focus on the advantages of filing patent applications using structured text (DOCX). Sessions will be offered on the following dates and times:

• Wednesday, November 13, 2019, 2:00–3:00 pm
• Tuesday, November 19, 2019, 11:00 am to noon
• Tuesday, November 26, 2019, 1:00–2:00 pm
• Wednesday, December 4, 2019, 2:00–3:00 pm
• Tuesday, December 10, 2019, 11:00 am to noon
• Wednesday, December 18, 2019, 2:00–3:00 pm

More information regarding the DOCX Information Sessions can be found here.

USPTO Releases Updated Legal Framework for Patent Electronic System

In a notice published in the Federal Register (84 Fed. Reg. 56803) last month, the U.S. Patent and Trademark Office announced the release of an updated legal framework for its Patent Electronic System. The updated legal framework, which can be found here, provides guidance on the background statutes, regulations, and policies that support the Office's Patent Electronic System, which comprises the EFS-Web and the Patent Application Information Retrieval (PAIR) system.

The notice indicates that the major differences in the updated legal framework are as follows:

1. Section B has been revised to further clarify that third-party papers are generally prohibited from being filed via EFS-Web unless specifically authorized.

2. Section D has been revised to clarify that providing an incorrect application number and confirmation number when filing a follow-on document will result in the follow-on document being entered in the wrong application. This may result in either the unintentional abandonment of the intended application for failure to reply to an Office action (or notice) or a reduction in patent term adjustment for failure to take reasonable steps to conclude processing or examination of an application. This may result in applicant having to file a petition to revive an unintentionally abandoned application.

3. Section E has been rewritten to discuss the two-step authentication method now being used to log into EFS-Web and Private PAIR. The two-step authentication method replaced the prior use of Public Key Infrastructure (PKI) certificates to access the Patent Electronic System. PKI certificates were discontinued on July 2, 2019.

USPTO Revises Portable Media Device Policy

In a Patent Alert e-mail distributed earlier this fall, the U.S. Patent and Trademark Office announced modifications to its portable media device policy. In particular, the Office notes that the use of personal removable media storage devices, including USBs, with any USPTO computer, docking station, or monitor are now prohibited. Prohibited devices include:

• Portable disk drives such as USB drives or memory cards
• Digital versatile discs (DVDs)
• Read/write compact discs (CDs)
• Devices that can operate as removable media storage devices (e.g., PDAs, digital cameras, and Apple iPods).

The Office also notes that visitors who need to share files with USPTO employees must transmit their data via e-mail, cloud-based, or secure-file sharing services. Additional information regarding the Office's removable media policy can be found here and questions can be directed to USB_Questions@uspto.gov. The new policy took effect on October 1, 2019.

USPTO Extends After-Final Consideration Pilot 2.0 Program

In a Patent Alert e-mail distributed earlier this fall, the U.S. Patent and Trademark Office announced that the After-Final Consideration Pilot 2.0 (AFCP 2.0) program has been extended to September 30, 2020.

The AFCP, which was implemented in April 2012 (see "USPTO to Assess After Final Consideration Pilot Program"), modified in May 2013 (see "USPTO News Briefs"), and extended several times since then, provides examiners with a limited amount of non-production time — three hours for utility and reissue applications — to consider responses filed following a final rejection. The requirements for participating in the AFCP 2.0 are as follows:

(1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);
(2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;
(3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the Office, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);
(4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and
(5) the required papers must be filed via the EFS-Web.

Additional information regarding the AFCP 2.0 program can be found on the Office's AFCP 2.0 webpage. Questions regarding the program can be directed to the Office's AFCP 2.0 e-mail address: afterfinalconsiderationpilotafcp20@uspto.gov.

USPTO Redesigns Website

In a Patent Alert e-mail distributed last month, the U.S. Patent and Trademark Office announced that it had redesigned the landing pages for the Patents, Trademarks, IP Policy, and Learning and Resources sections of its website. In addition to modifying the look and feel of these pages, based on stakeholder feedback and usability best practices, the Office has also provided a toolbar for commonly used USPTO transactional systems like EFS-Web, PAIR, TEAS, and TESS. Stakeholders who wish to participate in the testing of future web improvements or to provide feedback to the USPTO web team, can contact OCCOfeedback@uspto.gov.
BRCA2 Gene Mutations Associated with Risk of Childhood Lymphoma

November 11, 2019

By Kevin E. Noonan —

The BRCA2 gene is one member of a pair of genes that changed the patent landscape several years ago, when the Supreme Court ruled that "mere" isolation was insufficient to render genomic embodiments thereof patent eligible, in Association of Molecular Pathologists v. Myriad Genetics. As understood at the time patents on these genes were granted, certain mutations occurring in human populations were correlated with a higher risk of breast and ovarian cancer. Recently, a group of researchers found this gene seems to be involved with risk of non-Hodgkins lymphoma in children and adolescents.

The paper was published in JAMA Oncology, entitled "Association of Germline BRCA2 Mutations with the Risk of Pediatric or Adolescent Non-Hodgkins Lymphoma," by a research group* from St. Jude Children's Research Hospital. Spurred on by prior studies showing BRCA2 gene mutations were the third most frequent germline mutations identified in survivors of childhood lymphomas, these researchers studied an additional 794 lymphoma survivors by whole-genome sequencing of DNA from peripheral blood and buccal or saliva samples. Both single-nucleotide variants and insertion/deletion mutants (indels) were detected. These researcher reported detection of 177 mutants predicted to result in loss of function. The total number of survivors (1380) were made up of 815 Hodgkin lymphoma patients and 565 non-Hodgkins lymphoma patients. Of these, 748 were male and disease onset (median) was 13.4 years (although the range is wide: 1.1-22.7 years); 81 percent were Caucasian.

A total of thirteen mutations were detected in this population (although not expressly disclosed in their paper), five coming from Hodgkin lymphoma survivors and the rest from non-Hodgkins lymphoma survivors (the paper notes that all of the non-Hodgkins lymphoma survivors were male). There was a statistical significance in non-Hodgkins lymphoma not found in the Hodgkin lymphoma patients. These authors note that these patients are also at risk for adult neoplastic disease previously associated with cancer risk, as well as risk of pancreatic cancer, prostate cancer, and melanoma.

One reality illustrated by this paper is that the claims that Myriad's BRCA2 gene test would inhibit research and development of medical science were flatly false. This blog has discussed how the "gene" claims themselves would not be infringed by interrogating genomic DNA (see "The ACLU, Working for the Man"), and the detection method claims in the Myriad patents were limited to detecting BRCA2 gene mutations predictive of ovarian and breast cancer. Nowhere in the Myriad patents was there disclosure that would support a claim to a method of detecting a risk for childhood or adolescent non-Hodgkins lymphoma. And nowhere was there ever a risk that the Myriad patents would have prevented or even inhibited the research disclosed in this paper or any commercial application of it. Sadly, the ACLU's false narrative (recently reiterated during Senate hearings over proposed statutory reforms directed to ameliorating the most deleterious consequences of judicial persuasion to this erroneous point of view; see "ACLU (Predictably) Opposes Patent Subject Matter Eligibility Proposal") now limits such commercial development to the very companies least in need of exclusivity and who might reasonably choose to stick to already developed diagnostic methods rather than take the commercial risks associated with this new knowledge, no matter how much of an improvement it might provide. So much for the Court's decisions ensuring progress is promoted under its interpretation of the Patent Act.

* Wang, Zhaoming, PhD, Wilson, Carmen L., PhD, Armstrong, Gregory T., MD, Hudson, Melissa M., MD, Zhang, Jinghui, PhD, Nichols, Kim E., MD, Robison, Leslie L., PhD
Berkeley Files Opposition to Broad’s Substantive Motion No. 1 in Interference

November 10, 2019

By Kevin E. Noonan —

On October 18th, Junior Party (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its authorized opposition to Substantive Motion No. 1 from Senior Party the Broad Institute (and its partners as Senior Party, Harvard University and MIT), which asked for judgment in Interference No. 106,115 on the basis that CVC was estopped by prior judgment of no interference in fact in Interference No. 106,048 between these parties.

To recap, the Broad's motion asserted these arguments in favor of judgment:

CVC is estopped from getting a "second bite at the apple" in this interference by the provisions of 37 C.F.R. § 41.127(a)(1) and MPEP § 2308.03(b) (interference estoppel) because:

- this interference is directed to the same subject matter as the previous '048 patent (using the inclusion of the same Broad patents in this interference and the correspondence between the count in the '048 interference and claim 1 in involve U.S. Patent No. 8,697,359 in support)

- CVC is estopped from pursuing this interference on the grounds of judgment estoppel regarding issues that were raised or could have been raised in the earlier interference:

Judgment. (a) Effect within Office—(1) Estoppel. A judgment disposes of all issues that were, or by motion could have properly been, raised and decided. A losing party who could have properly moved for relief on an issue, but did not so move, may not take action in the Office after the judgment that is inconsistent with that party's failure to move, except that a losing party shall not be estopped with respect to any contested subject matter for which that party was awarded a favorable judgment [emphasis added].

The Broad argued that CVC had the opportunity in the '048 interference to file a responsive motion to the Broad's motion of no interference-in-fact to add claims directed to eukaryotic applications of CRISPR technology but did not. The Broad argues that this was a strategic decision by CVC to have only its "environment-free" claims in the interference. Furthermore, the Broad contends that it was intentional, citing to CVC's colloquy before the Board when the parties discussed which motion the Board would authorize, where CVC expressly "reserved" the ability to file such responsive motions.

The Broad's motion also asserts that the Board should not permit CVC to maintain the "cloud of uncertainty" regarding its patents, in its public statements and by pursuing "serial" interferences against the same Broad patents.

As is required under the procedural rules in interferences, CVC's opposition addresses each of these contentions in turn, including any disagreement over the facts the Broad put forward in support. Thus, CVC's first asserted opposition argument was that "judgment estoppel" (quotation marks in opposition brief) does not exist in any form that would prelude this interference. CVC's counter to the Broad's argument focuses on the existence vel non of a "losing" party in cases where no interference-in-fact are found. The brief characterizes as false the assumption that the subject matter of this interference is the same as the subject matter of the '048 interference. In the prior interference, it is undisputed that the Broad's claims were limited to practicing CRISPR in eukaryotic cells while CVC's claims-in-interference had no such restriction. That restriction (embodied in the Count) was imposed by the Board when the '048 interference was declared (and the Board never ruled on CVC's motion to change the count to remove this restriction. The scope of that earlier interference is different from this one, which is frankly directed towards using CRISPR solely in the eukaryotic background. According to CVC, this is the first time the priority question on practicing CRISPR solely in the eukaryotic cell context has been before the Board, and thus there should be no estoppel.

With regard to the Broad's arguments related to Rule 127, CVC contends that the Broad has misconstrued the meaning of the first sentence of the Rule. There is no per se "failure to move" requirement devoid of the need for a losing party in the prior interference (which does not exist in this case). The brief takes the opportunity to assert its priority argument in this section, arguing that CVC was "the first party to file a patent application identifying the necessary and sufficient components of a CRISPR-Cas system that cleaves or edits DNA," starting with its May 25, 2012 filing date, importantly encompassing its use without regard to cellular milieu.

The brief further addresses the assertions made that CVC was executing a "tactical decision" to "wage [a] serial interference campaign." On the contrary, CVC argues that it had suggested a count in the '048 interference that was cellular milieu-free, and it was the Board that restricted the count to use in eukaryotic cells. Nor, CVC contends, can its efforts to obtain patents on systems and uses of CRISPR in eukaryotic cells as "a mere attack" on the Broad's claims. CVC is jut doing what it was always intending to do, obtain broad and specific claim coverage for uses of CRISPR broadly. CVC also reminds the Board that, unlike in the '048 interference in this interference the Board declared it sua sponte (further blunting any allegations of manipulation or scheming, according to CVC). Having found interfering subject matter CVC argues that the Board ha a responsibility to declare an interference to resolve the priority issue under 35 U.S.C. §§ 102(g) and 135. CVC further argues that it is the Broad that has sought to avoid Board determination of the priority question, and points to its alleged motivation to do so: "[the] Broad was actually the fourth entity to file a patent application directed to CRISPR in eukaryotes" (citing facts CVC filed in support of tis opposition). The brief also makes sub silentio an argument regarding the Broad's (perfectly proper) prosecution strategy that accelerated examination of its CRISPR patents, and by "changing its applications' designation from post-AIA to pre-AIA during prosecution so that it could swear behind CVC's earlier-filed application." And CVC turns the Broad's victory in the earlier '048 interference against it, characterizing the Broad's successful pursuit of a finding of no interference-in-fact as another way to avoid final Board determination of the priority question (and similarly turns the Broad's allegations that CVC had a responsibility to move that the Board include claims to eukaryotic cell embodiments of CRISPR against the Broad, by alleging that it was the Broad that "could and should have moved to add a eukaryotic claim to CVC's involved application" as the proper alternative to seeking a finding of no interference-in-fact). Reminding the Board of the purported advantages of its alleged strategy, the brief states that:

Broad has enjoyed the benefits of its issued patents for five-and-a- half years but must now finally face the unresolved question of priority of invention for CRISPR in eukaryotes; no principles of collateral estoppel or res judicata prohibit the PTAB from resolving the issue now via this interference. Broad and the public have long been on notice that this issue remained unresolved as between Broad and CVC. The present interference, mandated by §§ 102(g) and 135, presents the proper vehicle for finally resolving priority of invention.

CVC's brief also addresses the estoppel issue, stating that interpreting estoppel as the Broad seeks in its motion would "invite the Office to commit legal error by exceeding its authority." Interference estoppel comes in two flavors, according to the brief: those set forth expressly in the enabling statute and those arising from common law. The latter are impliedly present in the statute because "Congress may be presumed, when enacting a statute granting to an agency adjudicatory authority, to mandate adherence to the doctrine of collateral estoppel," citing Duvall v. Atty. Gen., 436 F.3d 382, 387 (3d Cir. 2006). Here, the statute does not affirmatively set forth an estoppel and thus, according to CVC, any estoppel (including the "judicial estoppel" that is the basis for the Broad's prayer for relief in its motion, must arise from these common law principles. In addition, CVC argues that once Congress gives an agency authority to act, it "cannot promulgate or apply procedural rules in a manner that unilaterally contracts its jurisdiction to make it more narrow than what Congress has provided," citing Union Pac. R. Co. v. Bhd. 13 of Locomotive Engineers & Trainmen, 130 S. Ct. 584, 590 (2009). These arguments are relevant to CVC brief in two ways: first, the PTAB is not capable of promulgating rules on estoppel that go beyond the common law (absent express statutory authority absent here). Nor can the PTAB fail to satisfy its statutory mandate (here) to make priority determinations when priority of invention is in conflict.

With regard to the proper scope of estoppel, CVC argues that the Broad's interpretation of Rule 127 is contrary to these common law estoppel principles. CVC's first argument in support of its opposition in this regard is that this interference does not involve the same subject matter as the prior, '048 interference (making arguments substantially as set forth above on this point). While it is true that the Broad's claims in the earlier interference were limited to eukaryotic cell applications of CRISPR, CVC's were not, and thus this interference considering eukaryotic cell claims of both parties defines different subject matter. CVC's claims limited to eukaryotic cells in this interference are (and must be) patentably distinct from its claims in the '048 interference, because after all that distinction was the basis for the Broad having the PTAB (and the Federal Circuit) decide there was no interference-in-fact in the '048 interference:

The PTAB is now poised to answer who was first to invent CRISPR in eukaryotes. That question was not (and could not have been) litigated or decided in the previous interference given the no interference-in-fact determination. No principle of collateral estoppel or res judicata prevents deciding an issue that was not previously litigated,

according to CVC’s brief, citing B&B Hardware, Inc. v. Hargis Indus., Inc., 135 S. Ct. 1293, 1303 (2015); Biogen MA, Inc. v. Japanese Found. for Cancer Research, 785 F.3d 648, 658 (Fed. Cir. 2015); Purdue Pharma L.P., et al. v. Iancu, 2019 U.S. App. LEXIS 11205 (Fed. Cir. 2019); and Cromwell v. County of Sac, 94 U.S. 351, 353 (1877).

The brief makes a distinction between termination of an interference because no interference-in-fact is found (which, according to CVC, is a dismissal for lack of jurisdiction), which is not the same as a judgment and "does not preclude a second action based on the same cause of action that includes claims that overcome the initial defect of jurisdiction," citing, inter alia, Hughes v. U.S., 71 U.S. 232, 237 (1866). The proper analogy for a finding of no interference-in-fact is dismissal of a district court action for failure to state a claim, where res judicata arises only where the defect in the pleadings has not been cured.

CVC further faults the Broad's estoppel argument by noting that according to its terms Rule 127 raises an estoppel in the context of provoking an interference, whereas the '115 interference was declared sua sponte by the Board (exactly the type of procedural argument that frequently resonates with the Board; see "Sigma-Aldrich Tried Again"). Similarly, CVC's brief distinguishes MPEP 2308.03(b) from MPEP 2308.03(c) on the basis that the former rule of practice bars "any further interference between the same 2 parties for claims to the same invention as the count of the interference, [and] not any subsequent interference that presents a new question not previously litigated" (emphasis in brief). (And even if the PTAB disagrees with how CVC has parsed the MPEP, the brief asserts that "[t]o the extent that MPEP 2308.03(b) is construed to bar the present interference, the MPEP is contrary to the law and therefore invalid.") Finally, on these matters CVC disagrees that the scope of the count of the '048 interference has any weight or relevance, because if there was no interference-in-fact in the '048 interference there was no count that properly defined interfering subject matter.

CVC's brief then turns to the Broad's argument that CVC was under an obligation to move to include claims in the '048 interference directed to eukaryotic embodiments of CRISPR and that failing to do so raises an estoppel. Here CVC again raises objection to the Broad's interpretation of Rule 127, asserting (again) that the Rule requires there to be a losing party for estoppel to arise and a finding of no interference-in-fact does not produce a losing party. (The brief cites voluminous authority regarding the proper relationship between clauses or provisions of rules or statutes and their interpretation in support of this argument.) The brief notes (at least in part in contrast) that the Broad cited no authority for its (mis)interpretation of the Rule, and that its citation of commentary on the rulemaking that resulted in the provisions of the MPEP cited in the Broad's brief either does not support the Broad's interpretation of the Rule nor is the Board bound by them. CVC's conclusion is that:

[N]either Rule 127's text nor the rule-making comments state or imply that, following a judgment of no interference-in-fact, a non-losing party "who could have properly moved for relief on an issue, but did not so move, may not take action in the Office after the judgment that is inconsistent with the party's failure to move." 37 C.F.R. § 41.127(a)(1). That kind of failure-to-move estoppel is expressly reserved for a losing party, and limited to issues for which the losing party was not awarded favorable judgment. Id. Applying estoppel any more broadly would impose an inequitable result on a party that had not lost the prior proceeding.

CVC further blunts (or attempts to do so) in this portion of the brief the Broad's allegations that CVC's actions or inaction in the prior '048 interference were somehow improper or merely strategic, calling these characterizations a "mischaracterize[ation of] the facts." At least one set of these facts set forth in CVC's brief is that the Broad accuses CVC of not moving to include eukaryotic cell CRISPR claims in the '048 interference, when CVC had no such claims in condition for allowance (a requirement for the PTAB to make a priority determination) at that time. CVC also cites a Board Order in the prior interference, which stated that "[u]nder the facts and circumstances of this interference, where [CVC] believes all of its current claims interfere with all of Broad's claims, there is no reason why [CVC] should need to add a new claim. If [CVC]'s claims in other applications are ultimately found to be allowable, [CVC] may suggest additional interferences to the examiner" (emphasis in brief). Clearly, the position argued by the Broad is contrary to the terms of the Board's prior Order (at least as CVC interprets it) and may provide a basis for the Board to disregard this portion of the Broad's argument at a minimum and perhaps deny Substantive Motion No. 1.

The final Sections of CVC's brief address the Broad's assertion of equitable estoppel (which, according to CVC, would result in the Board to "abrogate its statutory mandates to decide interferences under § 135 and to issue patents to all those entitled to them under § 102); certain "policy considerations" that support the PTAB deciding the priority question ("it would contradict the PTAB's legislative mandate if it were to refrain from deciding the outstanding priority of invention issue, particularly where Broad's patents are facially invalid in view of CVC's earlier filed patent applications disclosing CRISPR in eukaryotes"); and that the Board must resolve certain disputed factual issues before deciding to grant the Broad's Substantive Motion No. 1.

Final Section VI of the brief provides CVC with an outcome that could snatch (ultimate) victory from the jaws of a defeat should the Board grant the Broad's Substantive Motion No. 1. Under those circumstances, CVC argues that the PTO has determined that CVC's claims are in condition for allowance but for the priority issues that have arisen under 35 U.S.C. §102(g). Thus, should the Board grant the Broad's motion the impediments to patentability raised by the Examiner would be overcome (i.e., there would be no violation of § 102(g)) and accordingly the Office should issue CVC's patents in due course. This would then give CVC the right to file an action in district court under § 291 to determine which of CVC and the Broad should properly have priority to the subject matter of eukaryotic cell embodiments of CRISPR. While not exactly a poison pill, such an outcome would not necessarily be estopped, because there would be two parties having granted claims to eukaryotic embodiments of CRISPR, and the public interest at a minimum would favor final resolution of the priority question. Of course the Broad recognized the possibility of this outcome and has asserted § 101 as a basis to preclude the Office from granting CVC's patents. While § 101 has been put to a great many uses during the past ten years, it clearly does not apply here (as CVC asserts), because "§ 101 simply bars issuing two patents to the same inventive entity; it says nothing about issuing a patent to a different inventive entity" (which is the provenance of § 102(g)).

The Broad's Reply brief is due March 20, 2020 unless the Board specifies an earlier date (which is likely).
USPTO Seeks Comments on Intersection of Intellectual Property and Artificial Intelligence in Second Federal Register Notice

November 7, 2019

By Aaron Gin —

On October 30, 2019, the U.S. Patent and Trademark Office released a Federal Register Notice requesting comments on issues of artificial intelligence (AI) and intellectual property, the second such request in the past three months.

In a blog post on the USPTO "Director's Forum", USPTO Director Andrei Iancu and Deputy Director Laura Peter stated that "[t]he fields of copyright, trademark, database protections, and trade secret law, among others, may be . . . susceptible to the impacts of developments in AI." As such, the USPTO has requested public feedback by way of thirteen questions involving topics ranging from whether an AI, without human intervention, can create a copyrightable work to whether and how AI might impact trade secret law. The Notice questions are summarized as follows:

1. Should a work produced by an AI algorithm or process, without the involvement of a natural person contributing expression to the resulting work, qualify as a work of authorship protectable under U.S. copyright law?

2. Assuming involvement by a natural person is or should be required, what kind of involvement would or should be sufficient so that the work qualifies for copyright protection? For example, should it be sufficient if a person (i) designed the AI algorithm or process that created the work; (ii) contributed to the design of the algorithm or process; (iii) chose data used by the algorithm for training or otherwise; (iv) caused the AI algorithm or process to be used to yield the work; or (v) engaged in some specific combination of the foregoing activities? Are there other contributions a person could make in a potentially copyrightable AI-generated work in order to be considered an "author"?

3. To the extent an AI algorithm or process learns its function(s) by ingesting large volumes of copyrighted material, does the existing statutory language (e.g., the fair use doctrine) and related case law adequately address the legality of making such use?

4. Are current laws for assigning liability for copyright infringement adequate to address a situation in which an AI process creates a work that infringes a copyrighted work?

5. Should an entity or entities other than a natural person, or company to which a natural person assigns a copyrighted work, be able to own the copyright on the AI work? For example: Should a company who trains the artificial intelligence process that creates the work be able to be an owner?

6. Are there other copyright issues that need to be addressed to promote the goals of copyright law in connection with the use of AI?

7. Would the use of AI in trademark searching impact the registrablity of trademarks?

8. How does AI impact trademark law? Is the existing statutory language in the Lanham Act adequate to address the use of AI in the marketplace?

9. How does AI impact the need to protect databases and data sets? Are existing laws adequate to protect such data?

10. How does AI impact trade secret law? Is the Defend Trade Secrets Act (DTSA), 18 U.S.C. 1836 et seq., adequate to address the use of AI in the marketplace?

11. Do any laws, policies, or practices need to change in order to ensure an appropriate balance between maintaining trade secrets on the one hand and obtaining patents, copyrights, or other forms of intellectual property protection related to AI on the other?

12. Are there any other AI-related issues pertinent to intellectual property rights (other than those related to patent rights) that the USPTO should examine?

13. Are there any relevant policies or practices from intellectual property agencies or legal systems in other countries that may help inform USPTO's policies and practices regarding intellectual property rights (other than those related to patent rights)?

In August, the USPTO previously requested comments on AI inventions with respect to patent law and policy. The questions from the first Notice covered a variety of patent-related topics, including whether revisions to patent laws may be needed. The current Notice extends similar inquiries to ask how AI may affect non-patent areas of IP (e.g., copyright, trademark, and other intellectual property rights). Notably, some of the questions could even foreshadow how examination procedures might evolve at the USPTO to include AI-based trademark searches. The Notice stated that public comments in these areas would aid the USPTO to evaluate whether further guidance to the Examining Corps is needed and to assist in the development of any such guidance with respect to intellectual property policy and its relationship with AI.

The USPTO has clearly made understanding the benefits/drawbacks of AI an action item for itself in the near future, on the policy front, and possibly in its own examination practice. The Notice itself pledges that "[t]he USPTO is committed to keeping pace with this critical technology in order to accelerate American innovation." Furthermore, the Patent Office has an open job posting for a "Senior Level Artificial Intelligence Technical Expert" whose responsibilities may include "operational implementation of Artificial Intelligence (AI) infrastructure/architecture throughout the enterprise." Going forward, it will be interesting to see how AI impacts existing patent and non-patent IP law and policy, as well as how AI-based innovations will be incorporated into the operation of the USPTO.

Written comments can be provided by email to AIPartnership@uspto.gov until December 16, 2019. Written comments will be made available for public inspection.

For additional information, please see:

• Second Federal Notice: Request for Comments on Intellectual Property Protection for Artificial Intelligence Innovation (FR Doc. 2019-23638).
• First Federal Notice: Request for Comments on Patenting Artificial Intelligence Inventions (FR Doc. 2019-18443).
• Andrei Iancu and Laura Peter, "USPTO issues second Federal Register Notice on artificial intelligence and innovation," Director's Forum: A Blog from USPTO's Leadership, October 30, 2019.
• Senior Level Artificial Intelligence Technical Expert, usajobs.gov, Announcement Number OCIO-2019-0010.

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